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Non-erythroid Effects of Erythropoietin on Cognitive Function and Exercise Capacity in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01889056
Recruitment Status : Unknown
Verified June 2013 by University of Zurich.
Recruitment status was:  Active, not recruiting
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

The blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the brain, especially under hypoxic conditions. It has been shown in animal studies and human studies that Epo has neuroprotective properties. Furthermore, there is scientific evidence for central modulatory effects of Epo in the brain but high dose of Epo is needed to overcome the blood brain barrier. In a double blind placebo controlled crossover study we will investigate the effects of a single high dose of Epo on cognitive function and exercise capacity in healthy subjects. The subjects will receive a single high dose of Epo (60.000 IU) and will perform a computerized cognitive test battery, a breathing test, a maximal exercise capacity test (VO2max), and a time trial (TT) 24 hours after the treatment. The primary outcome of the study will be the cognitive function.

  • Trial with medicinal product

Condition or disease Intervention/treatment Phase
Healthy Drug: Erythropoietin (Epoetin beta) Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Study Start Date : February 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Erythropoietin (Epoetin beta)
Short infusion of 60.000 IU Epoetin beta in 0.9% sodium chloride solution (250 ml)
Drug: Erythropoietin (Epoetin beta)
Other Name: Recormon

Placebo Comparator: 0.9% sodium chloride solution
Short infusion of 0.9% sodium chloride solution (250 ml)
Drug: Placebo
0.9% sodium chloride solution




Primary Outcome Measures :
  1. Cognitive Function [ Time Frame: 1 year ]

    The following parameters of cognitive function will be tested via computer-based cognitive testing (Units: Scores, Percent Correct, Response time):

    • Working memory capacity
    • Executive function
    • Processing speed


Secondary Outcome Measures :
  1. Exercise Capacity [ Time Frame: 1 year ]

    Evaluation of exercise capacity via specific exercise tests:

    • VO2max test
    • 20-minutes time trial (TT)


Other Outcome Measures:
  1. Subjective Well-Being [ Time Frame: 1 year ]

    Evaluation of subjective well-being via:

    • Questionnaires
    • Visual Analog Scales



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy Subjects;
  • Age between 18 to 35 years;
  • Normal body weight (body mass index of >= 18.5 kg/m2 <= 24.9 kg/m2);
  • Nonsmokers (>= 1 year);
  • VO2max of <= 55 ml/kg/min for females and <= 60 ml/kg/min for males;

Exclusion criteria:

  • Persons with abnormal Serum Ferritin levels according to gender dependent reference values of GCP-certificated laboratory;
  • Persons with pre-existing genetic hemostatic disorders (Factor V Leiden mutation, Prothrombin mutation);
  • Persons which are at risk of deep venous thrombosis (e.g. history of venous thromboembolic events);
  • Persons with a hematocrit value of > 55%;
  • Persons being exposed to prolonged (>= 5 days) high altitude (>= 2500m above Normal Null) <= 6 months prior the beginning of the study;
  • Persons not willing to maintain their living conditions during the study period (e.g. preparing for a certain competition);
  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;
  • Pregnant or breast feeding women;
  • Intention to become pregnant during the course of the study;
  • Lack of safe contraception;
  • Treatment with other investigational products;
  • Known or suspected non-compliance, drug or alcohol abuse;
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders;
  • Participation in another study with investigational drug within the 30 days preceding and during the present study;
  • Enrolment of the investigator, his/her family members, employees and other dependent persons;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889056


Locations
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Switzerland
University Hospital Zurich, Medical intensive care unit
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Marco Maggiorini, Prof MD University Hospital Zurich, Medical intensive care unit
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01889056    
Other Study ID Numbers: EPOPERF CH12
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013
Keywords provided by University of Zurich:
Erythropoietin
Cognition
Exercise
Additional relevant MeSH terms:
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Epoetin Alfa
Hematinics